KEY INDUSTRY INSIGHTS

Regulatory affairs service providers offer services such as product development, product registration, commercialization of the product, and others. Regulatory solutions in healthcare are essential as it provides co-ordination between international regulations and home government regulations, better manufacturing practice, new drug or medical device development support, product registration and approval, clinical trial exemptions and legal advice to healthcare institutions. The strive for successful product launch, high budget research, worldwide product approvals by the companies to survive in the highly competitive healthcare environment have increased the demand for contract-based regulatory solution providers.

Furthermore, strategic collaborations among the regulatory solution and service providers are poised to surge the market. For example, in November 2018, one of the major players in healthcare regulatory affairs outsourcing PAREXEL International Corporation and SHYFT Analytics, a company of Medidata Solutions agreed upon strategic partnership for providing Real-World Evidence (RWE) to biopharmaceutical and medical device manufacturing organizations.

Growing competition amongst healthcare companies, highly uncertain geopolitical conditions such as Brexit, stringent regulations & policies of the home government, and rising need for optimized healthcare resources are significant factors for the growth of the global healthcare regulatory affairs outsourcing market. Also, advantages of healthcare regulatory affairs outsourcing such as enhanced effectiveness in clinical operations, reduction in approval time, easy commercialization of product and assistance of strategic planning in product development & registration provided by regulatory affairs service providers are boosting the demand for regulatory affairs solutions and services.

However, lack of proper communication between regulatory affairs service provider companies and healthcare institutions has reported cases of cultural clash and difficulties in keeping track of service providers’ performance, which is a factor that can hinder the growth in the global healthcare regulatory affairs outsourcing market.

Among the service type, the software services segment is expected to have a remarkable growth during the projected period owing to the launch of advanced software for data and compliance management, ease of establishing co-ordination and communications, and rapid adoption of software.

Key Insights

PEST analysis

Healthcare regulatory affairs outsourcing service - pricing analysis

Recent industry developments such as partnerships, mergers, and acquisitions

Regional Analysis

North America is anticipated to dominate the global healthcare regulatory affairs outsourcing market during the forecast period owing to the rise in a number of patent expiry, focus on new product launch and approvals to compete in the healthcare environment. In Europe, the healthcare regulatory affairs outsourcing market is expected to have a significant expansion in the forecast duration due to the emphasis on cost reduction, focus on core competencies, and stringent government regulations. Asia Pacific is anticipated to emerge as a lucrative market for healthcare regulatory affairs outsourcing due to the increased efforts of pharmaceutical companies to establish distribution networks in emerging nations and rising need for optimum utilization of resources.

Key Industry Developments

In December 2018, GHO Capital Partners LLP, one of the European investor in healthcare acquired major stake of Validant, a consulting firm for regulatory affairs which is expected to accelerate to growth of the firm.

In November 2018, PAREXEL International Corporation and SHYFT Analytics, a company of Medidata agreed upon strategic partnership for providing Real-World Evidence (RWE) to biopharmaceutical and medical device manufacturing organizations.

In June 2018, Medidata announced the acquisition of SHYFT Analytics in view to aid life sciences companies to streamline their new product introduction to the market.